A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis
MISTRAL
A Single Arm, Open-Label, Multicentre Study to Assess the Maintenance of Haemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease on Peritoneal Dialysis
2 other identifiers
interventional
96
1 country
52
Brief Summary
This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2008
Typical duration for phase_3
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2008
CompletedFirst Posted
Study publicly available on registry
August 19, 2008
CompletedStudy Start
First participant enrolled
September 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2011
CompletedResults Posted
Study results publicly available
July 28, 2016
CompletedJune 23, 2017
May 1, 2017
2.8 years
August 18, 2008
June 17, 2016
May 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP
Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.
Weeks 16 to 24
Secondary Outcomes (12)
Percentage of Participants With Hb Values Within Target Range During the EEP
Weeks 16 to 24
Change in Hb Value From Baseline to the EEP
Baseline and Weeks 16 to 24
Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period
Weeks 16 to 24 and Weeks 0 to 48
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit
Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48
Percentage of Participants With Cycles or Excursions
Weeks 4 to 44
- +7 more secondary outcomes
Study Arms (1)
Mircera in Renal Anemia
EXPERIMENTALParticipants will receive SC methoxy polyethylene glycol-epoetin beta (Mircera) every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
Interventions
Mircera will be administered SC every 4 weeks for a total of 48 weeks. The first dose of 120 or 200 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
Eligibility Criteria
You may qualify if:
- Adults greater than or equal to (≥) 18 years of age
- Chronic kidney disease-related anemia on peritoneal dialysis for ≥3 months
- Continuous SC maintenance stable ESA therapy for 4 weeks prior to study start
You may not qualify if:
- Transfusion of red blood cells during previous 8 weeks
- Poorly controlled hypertension requiring interruption of ESA treatment in previous 6 months
- Significant acute or chronic bleeding during previous 8 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Ch Notre Dame Misericorde; Hemodialyse
Ajaccio, 20303, France
Centre Hospitalier; Hemodialyse
Annonay, 07103, France
Ch D Arras; Nephrologie
Arras, 62022, France
Ch D Auxerre; Nephrologie Hemodialyse
Auxerre, 89011, France
CHU Saint Jacques; Centre De Dialyse
Besançon, 25030, France
Ch Germon Et Gauthier; Hemodialyse
Beuvry, 62660, France
Polyclin Bordeaux Nord Aquitaine; Nephrologie - Hemodialyse
Bordeaux, 33077, France
Centre D Hemodialyse Saint Roch
Cabestany, 66330, France
Hopital Clemenceau; Nephrologie Hemodialyse
Caen, 14033, France
Hôpital Des Brousailles; Service de Néphrologie
Cannes, 06401, France
CH William Morey; Nephrologie
Chalon-sur-Saône, 71100, France
Ch De Chambery; Nephrologie
Chambéry, 73011, France
Hopital Manchester; Nephrologie Hemodialyse
Charleville-Mézières, 08011, France
Ch Hotel Dieu; Nephrologie
Chartres, 28018, France
Ch Du Cotentin Site De Cherbourg; Nephrologie
Cherbourg Octeville, 50102, France
Hopital Louis Pasteur; Nephrologie - Hemodialyse
Colmar, 68024, France
Ch Laennec; Nephrologie Hemodialyse
Creil, 60109, France
Hopital Du Bocage; Nephrologie
Dijon, 21079, France
Ch De Dunkerque; Nephrologie
Dunkirk, 59385, France
Chi Eure Seine D Evreux; Nephrologie
Évreux, 27023, France
Agduc Muller
La Tronche, 38701, France
Anider; Pharmacie
Le Petit-Quevilly, 76143, France
Hopital Calmette; Medecine General & Nephrologie Serv.
Lille, 59037, France
Ch Robert Bisson; Nephrologie
Lisieux, 14107, France
Aural
Lyon, 69008, France
Hopital Marc Jacquet; Nephrologie Hemodialyse
Melun, 77011, France
Hopital Saint Andre; Nephrologie
Metz, 57003, France
Echo Nantes Confluent; Uad Montfort
Nantes, 44202, France
Ch Georges Renon; Nephrologie Hemodialyse
Niort, 79021, France
Hopital de La Source; Service de Nephrologie & Hemodialyse
Orléans, 45100, France
Unite Autodialyse Paris 14; Dialyse A Domicile
Paris, 75014, France
Ch Pitie Salpetriere; Nephrologie Hemodialyse
Paris, 75651, France
Hopital Bichat Claude Bernard; Nephrologie
Paris, 75877, France
Hopital Tenon; Nephrologie Dialyse
Paris, 75970, France
Chu La Miletrie;Nephrologie Transplantation
Poitiers, 86021, France
Ch Rene Dubos; Dialyse Peritoneale
Pontoise, 95300, France
Chi De Cornouaille; Nephrologie
Quimper, 29107, France
Hopital De La Maison Blanche; Nephrologie Hemodialyse
Reims, 51092, France
Ch De Bourran; Nephrologie Hemodialyse
Rodez, 12027, France
Aurar; Aurar St Denis
Saint-Denis, 97400, France
Memorial France Etats Unis; Nephrologie
Saint-Lô, 50009, France
Hopital National; Nephrologie Hemodialyse
Saint-Maurice, 94415, France
Aurar
Saint-Pierre, 97410, France
HOPITAL NORD; NEPH Transplantation Reanimation
Saint-Priest-en-Jarez, 42277, France
CH de Saintonge; Unite 1 Med Interne Nephrologie
Saintes, 17108, France
Ch De Soissons; Medecine 5
Soissons, 02209, France
Hopital Civil; Nephrologie Clinique Medicale B
Strasbourg, 67091, France
Arauco; Arauco Tours Bretonneau
Tours, 37044, France
Ch De Valence; Departement Medecine
Valence, 26953, France
ALTIR
Vandœuvre-lès-Nancy, 54511, France
CH Bretagne Atlantique de Vannes; Hemodialyse
Vannes, 56017, France
Ch De Vittel; Nephrologie Hemodialyse
Vittel, 88804, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2008
First Posted
August 19, 2008
Study Start
September 30, 2008
Primary Completion
July 31, 2011
Study Completion
July 31, 2011
Last Updated
June 23, 2017
Results First Posted
July 28, 2016
Record last verified: 2017-05